SonoSite recalls L25 Bracket Kit (REF P03122-01 to P03122-05) due to risk of puncturing sterile covers during assembly. Affected units have specific lot numbers and missing labels.
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
SonoSite is recalling its L25 Bracket Kit because the reusable bracket could puncture the sterile cover during assembly. This poses a risk of infection or contamination for medical users. Affected units have specific reference numbers and lot ranges.
The reusable bracket is not sterile and could puncture the sterile cover over the transducer during assembly. This might lead to contamination or infection if the sterile cover is compromised.
Medical professionals using the SonoSite L25 ultrasound system may be affected. Those with the bracket kit containing reference numbers P03122-01 to P03122-05 are most at risk.
Check for reference numbers P03122-01 to P03122-05 on the bracket kit. Units with lot numbers between A000012-A050663, M000880-M995980, or missing product labels are affected.
Look for reference numbers P03122-01 to P03122-05 and lot numbers within the specified ranges on the bracket kit.
The bracket kit is not safe for use as it may puncture the sterile cover during assembly, increasing infection risk.
Check the reference numbers and lot numbers on the kit. If it matches the affected ranges, contact SonoSite for instructions.
Look for reference numbers P03122-01 to P03122-05 and lot numbers between A000012-A050663, M000880-M995980, or missing product labels.
We’ve drafted a message you can send SonoSite to request your refund or repair — edit it as you like.
Subject: Recall Z-0563-2019 — SonoSite SonoSite Hello, I own a SonoSite that is covered by recall Z-0563-2019 from SonoSite. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.